Trial Outcomes & Findings for Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission (NCT NCT02780401)
NCT ID: NCT02780401
Last Updated: 2024-09-19
Results Overview
Toxicities by grade that were related (possibly, probably or definitely) to the study vaccine noted during the immunization regimen will be summarized. This is done by arm, Grade and Attribution to study vaccine.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Up to 9 months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
|---|---|---|---|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
|
Overall Study
STARTED
|
10
|
12
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission
Baseline characteristics by cohort
| Measure |
Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim
n=10 Participants
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
Laboratory Biomarker Analysis: Correlative studies
pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine: Given ID
Sargramostim: Given ID
|
Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim
n=12 Participants
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
Laboratory Biomarker Analysis: Correlative studies
pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine: Given ID
Sargramostim: Given ID
|
Reatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim
n=10 Participants
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
Laboratory Biomarker Analysis: Correlative studies
pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine: Given ID
Sargramostim: Given ID
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
53 years
n=7 Participants
|
45 years
n=5 Participants
|
51.9 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - Non Hispanic Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown - Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
10 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 9 monthsToxicities by grade that were related (possibly, probably or definitely) to the study vaccine noted during the immunization regimen will be summarized. This is done by arm, Grade and Attribution to study vaccine.
Outcome measures
| Measure |
Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim
n=47 Count of Related Adverse Events per Arm
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim
n=54 Count of Related Adverse Events per Arm
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim
n=37 Count of Related Adverse Events per Arm
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
|---|---|---|---|
|
Number of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0
Grade 1 related adverse events
|
45 Count of Related Adverse Events per Arm
|
53 Count of Related Adverse Events per Arm
|
30 Count of Related Adverse Events per Arm
|
|
Number of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0
Grade 2 related adverse events
|
2 Count of Related Adverse Events per Arm
|
1 Count of Related Adverse Events per Arm
|
7 Count of Related Adverse Events per Arm
|
SECONDARY outcome
Timeframe: Up to 4 monthsImmune response will be measured by indirect enzyme-linked immunosorbent assay and serum antibody avidity to determine an avidity index before and after vaccination. Patients will be considered to have developed an antibody response if antigen specific IgG antibodies are both detectable and have moderate to high avidity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 9 monthsIFN-g (Th1) and IL-10 (Th2) T-cells will be evaluated using enzyme-linked immunosorbent spot assay. Patients will be considered to have developed a Th1 immune response as the sum IFN-Ɣ magnitude from all antigens to maximum response. This will be presented as a median fold change from baseline to the maximum response (1 or 6 months after vaccination).
Outcome measures
| Measure |
Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim
n=10 Participants
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim
n=9 Participants
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim
n=10 Participants
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
|---|---|---|---|
|
Assessment of T Helper Th1:Th2 Ratio
|
3.5 score on a scale
Interval 1.3 to 667.0
|
4.5 score on a scale
Interval -1.3 to 1377.0
|
1.2 score on a scale
Interval -3.8 to 5.7
|
SECONDARY outcome
Timeframe: Up to 24 weeksImmune responses will be measured by IFN-g enzyme-linked immunosorbent spot assay using blood (PBMC) represented by a maximum immune response generated to each antigen individually measured as corrected spots per well (cSPW). At the immune evaluations, each patient was given a value to indicate their immune response at both baseline and post vaccination. This data is represented by a median response, at both baseline (before vaccination) and 1 month or 6 months after the last vaccination of 3 vaccines (maximum response), to each of the 3 vaccine antigens HER2, IGFBP-2 or IGF1R.
Outcome measures
| Measure |
Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim
n=10 Participants
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim
n=10 Participants
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim
n=10 Participants
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
|---|---|---|---|
|
Assessment of the Immunogenicity of WOKVAC by Generation of IGFBP-2, HER2, and IGF-1R Specific Type 1 (Th1) T- Cells
HER2 - Baseline
|
92 correct spots per well (cSPW)/10^6 PBMC
Interval 2.5 to 1276.0
|
109 correct spots per well (cSPW)/10^6 PBMC
Interval 0.0 to 1218.0
|
402 correct spots per well (cSPW)/10^6 PBMC
Interval 92.0 to 1540.0
|
|
Assessment of the Immunogenicity of WOKVAC by Generation of IGFBP-2, HER2, and IGF-1R Specific Type 1 (Th1) T- Cells
HER2 - Maximum
|
639 correct spots per well (cSPW)/10^6 PBMC
Interval 14.0 to 1695.0
|
203 correct spots per well (cSPW)/10^6 PBMC
Interval 10.0 to 1034.0
|
237.5 correct spots per well (cSPW)/10^6 PBMC
Interval 0.0 to 1517.0
|
|
Assessment of the Immunogenicity of WOKVAC by Generation of IGFBP-2, HER2, and IGF-1R Specific Type 1 (Th1) T- Cells
IGF-1R - Baseline
|
0 correct spots per well (cSPW)/10^6 PBMC
Interval 0.0 to 0.0
|
0 correct spots per well (cSPW)/10^6 PBMC
Interval 0.0 to 508.0
|
107 correct spots per well (cSPW)/10^6 PBMC
Interval 0.0 to 477.0
|
|
Assessment of the Immunogenicity of WOKVAC by Generation of IGFBP-2, HER2, and IGF-1R Specific Type 1 (Th1) T- Cells
IGF-1R - Maximum
|
0 correct spots per well (cSPW)/10^6 PBMC
Interval 0.0 to 116.0
|
18 correct spots per well (cSPW)/10^6 PBMC
Interval 0.0 to 507.0
|
76 correct spots per well (cSPW)/10^6 PBMC
Interval 5.6 to 1172.0
|
|
Assessment of the Immunogenicity of WOKVAC by Generation of IGFBP-2, HER2, and IGF-1R Specific Type 1 (Th1) T- Cells
IGFBP-2 - Baseline
|
58.5 correct spots per well (cSPW)/10^6 PBMC
Interval 0.0 to 868.0
|
179 correct spots per well (cSPW)/10^6 PBMC
Interval 0.0 to 490.0
|
123 correct spots per well (cSPW)/10^6 PBMC
Interval 0.0 to 890.0
|
|
Assessment of the Immunogenicity of WOKVAC by Generation of IGFBP-2, HER2, and IGF-1R Specific Type 1 (Th1) T- Cells
IGFBP-2 - Maximum
|
184.5 correct spots per well (cSPW)/10^6 PBMC
Interval 2.8 to 661.0
|
215 correct spots per well (cSPW)/10^6 PBMC
Interval 16.0 to 459.0
|
207.5 correct spots per well (cSPW)/10^6 PBMC
Interval 7.5 to 355.0
|
SECONDARY outcome
Timeframe: Up to 6 months after the last vaccineAssessed by flow cytometry of peripheral blood mononuclear cells using an established T-cell activation panel and summarized with mean and standard deviation or median and range over time.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 weeksAssessed by flow cytometry of peripheral blood mononuclear cells using an established myeloid derived suppressor cell/ regulatory T-cell panel and summarized with mean and standard deviation or median and range over time.
Outcome measures
| Measure |
Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim
n=9 Participants
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim
n=10 Participants
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim
n=9 Participants
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
|---|---|---|---|
|
Modulation of Myeloid Derived Suppressor Cell Levels
|
0.00 percentage of m-MDSC
Interval 0.0 to 0.02
|
0.00 percentage of m-MDSC
Interval 0.0 to 0.08
|
0.01 percentage of m-MDSC
Interval 0.0 to 0.09
|
SECONDARY outcome
Timeframe: Up to 24 weeksAssessed by flow cytometry of peripheral blood mononuclear cells using an established myeloid derived suppressor cell/ regulatory T-cell panel and summarized with median and range. FOXP3 is used to identify regulatory T cells, specifically CD4+ cells isolated from PBMC.
Outcome measures
| Measure |
Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim
n=9 Participants
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim
n=10 Participants
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim
n=9 Participants
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
|---|---|---|---|
|
Modulation of T Regulatory Cell Levels
|
8 % of Foxp3+ cells among CD4+ cells
Interval 3.0 to 9.0
|
5 % of Foxp3+ cells among CD4+ cells
Interval 3.0 to 8.0
|
4 % of Foxp3+ cells among CD4+ cells
Interval 3.0 to 7.0
|
Adverse Events
Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim
Serious events: 0 serious events
Other events: 12 other events
Deaths: 1 deaths
Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim
Serious events: 0 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim
n=10 participants at risk
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim
n=12 participants at risk
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim
n=10 participants at risk
Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
General disorders
Edema face
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
General disorders
Edema limbs
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Eye disorders
Eye Disorder - Other
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
General disorders
Fatigue
|
50.0%
5/10 • Number of events 8 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
25.0%
3/12 • Number of events 4 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
2/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Gastrointestinal disorders
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
16.7%
2/12 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
2/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Investigations
Alanine
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
16.7%
2/12 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Gastrointestinal disorders
Bloating
|
10.0%
1/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Reproductive system and breast disorders
Breast pain
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
25.0%
3/12 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
20.0%
2/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
25.0%
3/12 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
20.0%
2/10 • Number of events 4 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Cardiac disorders
Chest pain
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
General disorders
Chills
|
40.0%
4/10 • Number of events 5 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
41.7%
5/12 • Number of events 8 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10 • Number of events 5 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
16.7%
2/12 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
4/10 • Number of events 4 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
33.3%
4/12 • Number of events 5 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
50.0%
5/10 • Number of events 7 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
25.0%
3/12 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
30.0%
3/10 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
20.0%
2/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
25.0%
3/12 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
20.0%
2/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
General disorders
Flu like symptoms
|
50.0%
5/10 • Number of events 6 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
66.7%
8/12 • Number of events 11 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
20.0%
2/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Vascular disorders
Flushing
|
20.0%
2/10 • Number of events 4 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
16.7%
2/12 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • Number of events 5 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
33.3%
4/12 • Number of events 10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
30.0%
3/10 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Metabolism and nutrition disorders
Glucose
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
33.3%
4/12 • Number of events 4 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
20.0%
2/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Vascular disorders
Hypertension
|
70.0%
7/10 • Number of events 11 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
16.7%
2/12 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Metabolism and nutrition disorders
Hyperthyroidism
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
16.7%
2/12 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
40.0%
4/10 • Number of events 5 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
16.7%
2/12 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
30.0%
3/10 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
25.0%
3/12 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
20.0%
2/10 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
20.0%
2/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
2/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Infections and infestations
Infections and Infestations - Other
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
25.0%
3/12 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
General disorders
Injection site reaction
|
90.0%
9/10 • Number of events 14 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
83.3%
10/12 • Number of events 17 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
70.0%
7/10 • Number of events 13 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Investigations
Investigations - Other
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Investigations
Complement 3
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
16.7%
2/12 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
20.0%
2/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Vascular disorders
Lymphedema
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Investigations
Lymphocyte count decreased
|
70.0%
7/10 • Number of events 7 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
33.3%
4/12 • Number of events 4 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
50.0%
5/10 • Number of events 5 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Investigations
GAD65
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
10.0%
1/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Investigations
ANA
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
General disorders
Malaise
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
5/10 • Number of events 7 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
50.0%
6/12 • Number of events 7 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - other
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
16.7%
2/12 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
6/10 • Number of events 11 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
25.0%
3/12 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
30.0%
3/10 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
General disorders
Non-cardiac chest pain
|
30.0%
3/10 • Number of events 5 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
General disorders
Pain
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
25.0%
3/12 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Nervous system disorders
Phantom pain
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
16.7%
2/12 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Investigations
Platelet count decreased
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
20.0%
2/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
40.0%
4/10 • Number of events 5 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
33.3%
4/12 • Number of events 6 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
20.0%
2/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
20.0%
2/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Renal and urinary disorders
Renal calculi
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
25.0%
3/12 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Nervous system disorders
Somnolence
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
20.0%
2/10 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Infections and infestations
Upper respiratory infection
|
20.0%
2/10 • Number of events 3 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Infections and infestations
Urinary tract infection (UTI)
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 2 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
8.3%
1/12 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/10 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
0.00%
0/12 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
10.0%
1/10 • Number of events 1 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
|
Investigations
White blood cell decreased
|
50.0%
5/10 • Number of events 5 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
50.0%
6/12 • Number of events 7 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
40.0%
4/10 • Number of events 4 • Adverse events including Serious Adverse Events (SAEs) will be collected through the 6 month follow-up visit (total of 9 months). This is the incidence of all reported adverse events regardless of attribution.
|
Additional Information
Jennifer S. Childs
University of Washington Medical Center
Phone: 2066162305
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place